Levetiracetam (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levetiracetam Tablets USP

Rx Only

250 mg

NDC 68180-112-02

500’s Bottle Pack

figure 10
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figure 11
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Levetiracetam Tablets USP

Rx Only

500 mg

NDC 68180-113-02

500’s Bottle Pack

figure 12
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fig 13
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Levetiracetam Tablets USP

Rx Only

750 mg

NDC 68180-114-02

500’s Bottle Pack

14
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15
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Levetiracetam Tablets USP

Rx Only

1000 mg

NDC 68180-115-02

500’s Bottle Pack

16
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17
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LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-112
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 250 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
FD&C BLUE NO. 2
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL
POVIDONE
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (Blue) Score 2 pieces
Shape OVAL (Oblong-shaped, Biconvex, Film-Coated) Size 15mm
Flavor Imprint Code L;U;X01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-112-16 120 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57297-112-02 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57297-112-09 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078154 01/01/2009
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-113
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL
POVIDONE
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (Yellow) Score 2 pieces
Shape OVAL (Oblong-shaped, Biconvex, Film-Coated) Size 18mm
Flavor Imprint Code L;U;X02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-113-09 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57297-113-16 120 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57297-113-02 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078154 01/01/2009
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-114
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 750 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
FERRIC OXIDE RED
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL
POVIDONE
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE (Orange) Score 2 pieces
Shape OVAL (Oblong-shaped, Biconvex, Film-Coated) Size 20mm
Flavor Imprint Code L;U;X03
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-114-09 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57297-114-16 120 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57297-114-02 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078154 01/01/2009
LEVETIRACETAM levetiracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-115
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 1000 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POLYVINYL ALCOHOL
POVIDONE
SILICON DIOXIDE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape OVAL (Oblong-shaped, Biconvex, Film-Coated) Size 22mm
Flavor Imprint Code L;U;X04
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-115-07 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57297-115-02 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090025 01/15/2009
Labeler — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 manufacture (57297-112), manufacture (57297-113), manufacture (57297-114), manufacture (57297-115), pack (57297-112), pack (57297-113), pack (57297-114), pack (57297-115)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 863645527 manufacture (57297-112), manufacture (57297-113), manufacture (57297-114), manufacture (57297-115), pack (57297-112), pack (57297-113), pack (57297-114), pack (57297-115)

Revised: 05/2016 LUPIN LIMITED

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